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A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients

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Abstract

Background

Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study.

Methods

Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery.

Results

A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively.

Conclusions

This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute malignant colonic obstruction.

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Acknowledgments

This study was conducted with Japan Gastroenterological Endoscopy Society funding support and the Colonic Stent Safe Procedure Research Group membership dues.

Author information

Authors and Affiliations

  1. Division of Surgery, Gastrointestinal Center, Yokohama Shin-Midori General Hospital, 1726-7 Tokaichiba-cho, Midori-ku, Yokohama, 226-0025, Japan

    Shuji Saito

  2. Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan

    Shuntaro Yoshida

  3. Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan

    Hiroyuki Isayama

  4. Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Moroyama, Japan

    Takeaki Matsuzawa

  5. Department of Gastroenterology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Japan

    Toshio Kuwai

  6. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan

    Iruru Maetani

  7. Department of Surgery, Moriguchi Keijinkai Hospital, Moriguchi, Japan

    Mamoru Shimada

  8. Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan

    Tomonori Yamada

  9. Department of Surgery, Kishiwada Tokushukai Hospital, Kishiwada, Japan

    Masafumi Tomita

  10. Department of Gastroenterology, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital, Tokyo, Japan

    Koichi Koizumi

  11. Department of Gastroenterology, Kameda Medical Center, Kamogawa, Japan

    Nobuto Hirata

  12. Department of Surgery, National Hospital Organization Sagamihara Hospital, Sagamihara, Japan

    Hideki Kanazawa

  13. Department of Surgery, Toho University Ohashi Medical Center, Tokyo, Japan

    Toshiyuki Enomoto & Yoshihisa Saida

  14. Department of Surgery, National Hospital Organization Yokohama Medical Center, Yokohama, Japan

    Hitoshi Sekido

Authors
  1. Shuji Saito
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  2. Shuntaro Yoshida
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  3. Hiroyuki Isayama
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  4. Takeaki Matsuzawa
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  5. Toshio Kuwai
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  6. Iruru Maetani
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  7. Mamoru Shimada
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  8. Tomonori Yamada
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  9. Masafumi Tomita
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  10. Koichi Koizumi
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  11. Nobuto Hirata
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  12. Hideki Kanazawa
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  13. Toshiyuki Enomoto
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  14. Hitoshi Sekido
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  15. Yoshihisa Saida
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Corresponding author

Correspondence to Shuji Saito.

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Disclosures

Dr. Shuji Saito has received personal fees from Boston Scientific Japan, Century Medical Inc; Dr. Shuntaro Yoshida has received personal fees from Boston Scientific Japan, Century Medical Inc and ZEON Co, Dr. Hiroyuki Isayama has received donations and personal fees from Boston Scientific Japan, Century Medical Inc and Taewoong Medical Devices Inc. Drs. Takeaki Matsuzawa, Toshio Kuwai, and Mamoru Shimada have received personal fees from Boston Scientific Japan; Dr. Iruru Maetani has received personal fees from Boston Scientific Japan, Century Medical Inc, Piolax Medical Device Inc, and MC Medical Inc; Dr. Koichi Koizumi has received personal fees from Century Medical Inc and Olympus Medical Systems Corp; and Dr. Yoshihisa Saida has received grants and personal fees from Boston Scientific Japan, Century Medical Inc, and Olympus Medical Systems Corp. Drs. Tomonori Yamada, Masafumi Tomita, Nobuto Hirata, Hideki Kanazawa, Toshiyuki Enomoto, and Hitoshi Sekido have no conflicts of interest or financial ties to disclose.

Appendix

Appendix

The Colonic Stent Safe Procedure Research Group includes the following members in addition to the authors.

Tatsuya Osuga, Aijinkai Takatsuki General Hospital, Takatsuki, Japan; Masaki Kikkawa, Akita Red Cross Hospital, Akita, Japan; Mitsuru Goto, Asahikawa Kosei Hospital, Asahikawa, Japan; Shungo Endo, Fukushima Medical University Aizu Medical Center, Aizu-wakamatsu, Japan; Sayo Kobayashi, Fukuyama City Hospital, Fukuyama, Japan; Shigeru Yamagishi, Fujisawa City Hospital, Fujisawa, Japan; Ken Konishi, Higashiosaka City General Hospital, Higashiosaka, Japan; Masanori Yoshimitsu, Hiroshima City Asa Hospital, Hiroshima, Japan; Satoshi Ikeda, Hiroshima Prefectural Hospital, Hiroshima, Japan; Rintaro Moroi, Iwate Prefectural Isawa Hospital, Oshu, Japan; Michiaki Watanabe, Kawaguchi Municipal Medical Center, Kawaguchi, Japan; Hirofumi Kawamoto, Kawasaki Medical School, Okayama, Japan; Hirotoshi Hasegawa, Keio University School of Medicine, Tokyo, Japan; Atsushi Yamauchi, Kitano Hospital, Osaka, Japan; Fuminori Teraishi, Kochi Health Sciences Center, Kochi, Japan; Kohei Takayasu, Kyorin University Hospital, Mitaka, Japan; Takahiro Horimatsu, Kyoto University Hospital, Kyoto, Japan; Yoshinori Kushiyama, Matsue Red Cross Hospital, Matsue, Japan; Hiroaki Naota, Matsusaka Chuo General Hospital, Matsusaka, Japan; Takuya Yamaguchi, Mimihara General Hospital, Sakai, Japan; Shigenori Masaki, Miyanomori Memorial Hospital, Sapporo, Japan; Taku Sakamoto, National Cancer Center Hospital, Tokyo, Japan; Kazuhiro Watanabe, National Center for Global Health and Medicine, Tokyo, Japan; Masafumi Inomata, Oita University Faculty of Medicine, Oita, Japan; Nobuya Obana, Osaki Citizen Hospital, Osaki, Japan; Masayoshi Horimoto, Osaka Saiseikai Senri Hospital, Suita, Japan; Rika Kyo, Saiseikai Yokohamashi-Nanbu Hospital,Yokohama, Japan; Shinei Kudo, Showa University Northern Yokohama Hospital, Yokohama, Japan; Yasushi Nakamura, Takano Hospital, Kumamoto, Japan; Mitsunori Ushigome, Toho University Omori Medical Center, Tokyo, Japan; Takeshi Ohki, Tokyo Women’s Medical University, Tokyo, Japan; Hiroyuki Kato, Tokyo Women’s Medical University Medical Center East, Tokyo, Japan; Shiro Hayashi, Toyonaka Municipal Hospital, Toyonaka, Japan; Tomio Hirakawa, Yao Tokushukai General Hospital, Yao, Japan; and Kensuke Kubota, Yokohama City University Hospital, Yokohama, Japan.

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Saito, S., Yoshida, S., Isayama, H. et al. A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients. Surg Endosc 30, 3976–3986 (2016). https://doi.org/10.1007/s00464-015-4709-5

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